Drug Safety Monitoring Committee Approval to Proceed to Final Six
Patients of Twelve

First-in-human trial on safety and tolerability passes key stage-gate

June 28, 2017 09:37 PM Eastern Daylight Time

SYDNEY--(EON: Enhanced Online News)--Australian immuno-oncology company Minomic International Ltd is
proceeding to the second stage of its pioneering MILGa clinical trial of
MiltuximabTM, a chimeric version of Minomic’s MIL-38
anti-Glypican 1 antibody conjugated to the radioactive isotope 67Gallium.

“The results
from this trial are providing us with important safety data as well as
telling us how well the antibody targets different tumour types. We will
use this information to guide the future development of the drug.”

The MILGa Cancer Imaging Trial is a first-in-human study to evaluate the
safety and tumor targeting of MiltuximabTM in patients with
metastatic prostate, bladder, and pancreatic cancer. The primary
endpoint of the MILGa trial is safety and tolerability of the MiltuximabTM
drug. Secondary endpoints include tumor targeting, pharmacokinetics and
dosimetry to determine relative accumulation of MILGa in different
organs.

Following a pre-specified interim analysis of safety data from the first
six patients, the trial’s independent Drug Safety Monitoring Committee
has formally approved the continuation of the clinical trial to the
final six of twelve subjects.

The first half of the study dosed two patients with pancreatic cancer
and four with prostate cancer. MILGa was well tolerated and no drug
related adverse events were reported.

The Minomic Drug Safety Monitoring Committee is drawn from
radiopharmaceutical and oncology groups at two major public hospitals in
Sydney, Australia. The Committee comprises Dr Vijay Kumar, Head of
Radiopharmaceutical Research at Westmead Hospital, and Dr Matteo Carlino
and Dr Bo Gao, who are both Staff Specialists Medical Oncology at
Blacktown and Westmead Hospitals.

Preclinical studies have demonstrated that MILGa accurately targets
prostate, pancreatic, and bladder cancer cells, and is well-tolerated
and highly specific in mouse models of prostate cancer.

Minomic’s Chief Executive Officer, Dr Brad Walsh, said, “The results
from this trial are providing us with important safety data as well as
telling us how well the antibody targets different tumour types. We will
use this information to guide the future development of the drug.”

“Passing this key formal stage in our trial is very encouraging,” he
added. “There are no approved antibody therapies for prostate or
pancreatic cancer, whilst bladder cancer remains extremely expensive to
treat. There is therefore the potential for major advances in the
treatment of these cancers.”

About MIL-38

MiltuximabTM is an IgG1 murine monoclonal antibody (mAb)
directed against Glypican-1 (GPC-1), with demonstrated strong reactivity
to prostate, bladder and pancreatic cancer cell lines. GPC-1 is also
overexpressed in other cancer types, such as oesophageal cancers and
glioblastoma.

About Minomic

Minomic International Ltd is an Australian immuno-oncology company
specialising in therapeutics and diagnostics for solid tumors, including
prostate, bladder and pancreas. Minomic has developed an in vitro
diagnostic test called the MiCheck® test for the detection of prostate
cancer. Minomic is preparing to globally launch the MiCheck® test, which
has been shown to be more than twice as specific as the existing gold
standard Prostate Specific Antigen (PSA) screening technology. This
means that MiCheck® delivers only 1.5 false positives from every ten
samples, compared to 6 false positive results in every 10 samples using
the standard PSA test. The MiCheck® technology uses Glypican-1, a
recently identified biomarker and other biomarkers never previously used
in prostate cancer diagnosis. Minomic is interested in partnerships or
collaborations with larger pharmaceutical/diagnostic global partners
able to produce, register and distribute the MiCheck® test and
collaborate through registration and commercialization of future
diagnostic imaging and therapeutic applications of the MIL-38 antibody
for prostate cancer.

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Release Summary

Drug Safety Monitoring Committee Approval to Proceed to Final Six Patients. First-in-human trial on safety and tolerability passes key stage-gate.